Enterotoxigenic Escherichia Coli (ETEC) ETVAX Vaccine Trial in Bangladesh

Summary

The purpose of this study is to determine if the ETEC vaccine ETVAX with and without dmLT adjuvant is safe and immunogenic in adults, children, toddlers and infants in Bangladesh.

Timeline

Start

2015-10

Primary completion

2017-07-29

Completion

2017-07-29

Publications

• Higginson EE, Sayeed MA, Pereira Dias J, Shetty V, Ballal M, Srivastava SK, Willis I, Qadri F, Dougan G, Mutreja A. Microbiome Profiling of Enterotoxigenic Escherichia coli (ETEC) Carriers Highlights Signature Differences between Symptomatic and Asymptomatic Individuals. mBio. 2022 Jun 28;13(3):e0015722. doi: 10.1128/mbio.00157-22. Epub 2022 May 10.
• Qadri F, Akhtar M, Bhuiyan TR, Chowdhury MI, Ahmed T, Rafique TA, Khan A, Rahman SIA, Khanam F, Lundgren A, Wiklund G, Kaim J, Lofstrand M, Carlin N, Bourgeois AL, Maier N, Fix A, Wierzba T, Walker RI, Svennerholm AM. Safety and immunogenicity of the oral, inactivated, enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi children and infants: a double-blind, randomised, placebo-controlled phase 1/2 trial. Lancet Infect Dis. 2020 Feb;20(2):208-219. doi: 10.1016/S1473-3099(19)30571-7. Epub 2019 Nov 19.
• Akhtar M, Chowdhury MI, Bhuiyan TR, Kaim J, Ahmed T, Rafique TA, Khan A, Rahman SIA, Khanam F, Begum YA, Sharif MZ, Islam LN, Carlin N, Maier N, Fix A, Wierzba TF, Walker RI, Bourgeois AL, Svennerholm AM, Qadri F, Lundgren A. Evaluation of the safety and immunogenicity of the oral inactivated multivalent enterotoxigenic Escherichia coli vaccine ETVAX in Bangladeshi adults in a double-blind, randomized, placebo-controlled Phase I trial using electrochemiluminescence and ELISA assays for immunogenicity analyses. Vaccine. 2019 Sep 3;37(37):5645-5656. doi: 10.1016/j.vaccine.2018.11.040. Epub 2018 Nov 22.

Drugs

Indications